510(k) K962226

PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM by Johnson & Johnson Medical, Inc. — Product Code FOZ

K962226 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Medical, Inc. for the device "PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM". The FDA issued a decision of Substantially Equivalent on December 23, 1996. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Johnson & Johnson Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1996
Date Received
June 10, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type